Appeal from the United States District Court for the Eastern District of Wisconsin. No. 71-C-158. MYRON L. GORDON, Judge. Appeal from the United States District Court for the Northern District of Illinois, Eastern Division. No. 70-C-2246. JAMES BENTON PARSONS, Judge.
Hastings, Senior Circuit Judge, and Stevens and Sprecher, Circuit Judges.
There are two ways to state the principal question presented by these appeals. Narrowly, the issue is whether residues of DDT and dieldrin smoked chubs are "food additives" within the meaning of § 201(s) of the Federal Food, Drug and Cosmetic Act.*fn1 A somewhat more disturbing way to state the same question is whether all of the fish in the Great Lakes are "adulterated" as a matter of statutory definition.*fn2 If they are, the Administrator*fn3 may have, at least for the present, virtually unbridled power to eliminate all such fish from our food supply. We therefore attach special importance to the additional questions presented in the Vita Food appeal. That appeal, unlike the Ewig Bros. appeal,*fn4 requires us to consider the legal significance of an "interim guideline" announced in a press release on April 22, 1969, as well as the district court's findings that the testing methods used by the government's experts were not sufficiently reliable to demonstrate that Vita's smoked chubs contained more DDT than the guideline permits.
A total ban on the future use of DDT would not resolve the problem presented by this case. Although the levels of DDT contamination are declining, we must assume that the chemical, or its derivatives, will survive as an ingredient of all or most foods for some time.*fn5
Scientists seem to agree that if the DDT level is high enough, the food should not be consumed by man and, conversely, if the amount is sufficiently small, ingestion of DDT may be harmless. Danger levels have not been precisely defined. The record demonstrates, however, that in fish levels in the range of 5 parts per million are neither (a) generally recognized among qualified experts as safe,*fn6 nor (b) demonstrably injurious to health or unfit for human consumption.*fn7 At the levels disclosed by the record before us, the effect on human health is somewhat uncertain.
Unquestionably DDT is a "pesticide chemical" as that term is defined in § 201(q) of F.D.C.A. See 21 U.S.C. § 321(q). Pursuant to statutory procedures, tolerances have been established for its use in or on various raw agricultural commodities, including fruits, vegetables, and meat.*fn8 Such foods may therefore contain DDT within the prescribed tolerance limits without being "adulterated." It does not follow, however, that a level which is either safe or unsafe for one food would be equally safe or unsafe for another food.*fn9 With respect to the foods for which DDT tolerances have been set, it is reasonable to infer that the rule-making process may have been invoked either by the FDA itself, by manufacturers or distributors of the pesticide, or by farmers or producers who are interested in using DDT as a pesticide. Fishermen, however, have never had any interest in using or selling DDT themselves; its presence in the environment is a condition of their work -- and also of the business of distributing or processing fish -- for which they are not responsible and which they have no interest whatsoever in perpetuating. In short, unlike farmers and pesticide salesmen, they have never had any interest in adding DDT to the environment or to the food supply. From their point of view, it is not an item which is added to their products; it is a natural component of the fish before it is caught, let alone processed.
In this case the government's claim that defendants' chubs are "adulterated" is not predicated on a claim that the particular fish defendants sell contain a poisonous substance or are otherwise unfit for food pursuant to either subparagraph (1) or subparagraph (3) of § 402 of the F.D.C.A.*fn10 Under those subparagraphs the government would have the burden of proving that the fish are actually harmful to man. Instead, the government's claim is predicated on § 402(a)(2)(C),*fn11 under which it need only prove that "such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures . . . to be safe under the conditions of its intended use . . . ." § 201(s) of the F.D.C.A., 21 U.S.C. § 321(s).*fn12
It is the government's position that a fair analysis of the statutory scheme Congress has enacted, including the allocation of decision-making responsibility between the agency and the judiciary, justifies proceeding under this section. For if, as the government contends, DDT is a food additive, the Food and Drug Administration may itself decide when products containing quantities of DDT should be removed from public consumption, without having to rely upon the decisions -- possibly inconsistent with one another -- of different federal judges determining danger to health under §§ (a)(1) and (a)(3) on a case-by-case basis.
The question, then, is whether DDT and dieldrin in defendants' processed fish are "food additives" within the meaning of § 201(s).
We have recently identified the principal purposes of the food additive amendment of 1958.*fn13 Neither the purpose to establish a procedure for premarketing clearance of untested food additives, nor the intent to permit the evaluation of such products to encompass a consideration of their benefits, as well as their potential for harm, seems directly relevant to the question before us. Rather, we are concerned with products which, at least primarily, were intended to be regulated as pesticide chemicals rather than as food additives. It is therefore appropriate to review the development of the pesticide chemical legislation enacted in 1954 as well as the food additive amendment itself.
Prior to 1938 a poisonous substance added to a food during processing would not cause adulteration unless the government could prove that the food itself, as opposed to the added substance, was unsafe.*fn14 After 1938, however, the statute has focused attention on the character of the added substance. Section 406 of the 1938 Act prohibited the use of poisonous or deleterious substances unless industry demonstrated that the substance was required for processing and also persuaded the Administrator*fn15 to issue a tolerance regulation permitting use in amounts below a specified level. Pending the promulgation of such a tolerance regulation, the addition of any poisonous or deleterious substance -- even traces which could not possibly affect the safe character of the end product -- constituted adulteration as a matter of law.*fn16 The "per se" approach adopted in 1938 placed the burden of proving safety upon industry and, as a matter of procedure, mandated marketing delays until after formal administrative review could be completed.
Although the 1938 Act authorized the promulgation of regulations limiting the amount of pesticide residues that remain in or on food (since such chemicals were obviously "poisonous or deleterious"), only one such regulation was actually issued during the subsequent 15-year period. The absence of such formal tolerance regulations was attributable, in part, to the expense and complexity of the rule-making procedure and, in part, to the required showing that use of the added substance be essential or unavoidable during processing.*fn17 Instead of employing ...